Phathom Pharmaceuticals, Inc.

Q4 2023 Earnings Conference Call

3/7/2024

spk02: Hello and welcome to the Fathom Pharmaceuticals fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. With that, I would like to turn the conference over to Eric Chiarelli, Fathom's Head of Investor Relations. Please go ahead.
spk09: Thank you, Operator. Hello, everyone, and thank you for joining us this morning to discuss Fathom's fourth quarter and full year 2023 results. This morning's presentation will include remarks from Terry Curran, our President and CEO, Martin Gilligan, our Chief Commercial Officer, and Molly Henderson, our Chief Financial Officer. Azmi Nabulsi, our Chief Operating Officer, will also be joining the team during the Q&A portion of today's call. Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found under the News Releases section of our corporate website. Further, the recording of today's webcast can be found under the events and presentation section of our corporate website. Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond Fathom's control. Actual results can materially differ from the forward-looking statements, and any such risk can materially adversely affect the business, the results of operations, and trading prices for Fathom's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide, as well as in the risk factors section of our most recent Form 10-K and subsequent SEC filings. All forward-looking statements made on this call are based on the beliefs of FATHOM as of this date, and FATHOM disclaims any obligation to update these statements. Also included today are non-GAAP financial measures, which should be considered only as supplemental to and not a substitute for or superior to GAAP measures. To the extent applicable, please refer to the tables at the end of this morning's press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures. With that, I will now turn the call over to Terry Curran, BADM's President and CEO, to kick us off. Terry?
spk03: Thank you, Eric, and thank you to all those joining us on today's call. This is our first earnings call as a commercial company, and I'm excited to report on the progress we've made during both the fourth quarter, 2023, and the start of the calendar year, 2024. In that short period, we've achieved many regulatory, manufacturing, financial, and commercial milestones, demonstrating the significant experience and dedication of our teams. In November we set out with three initial goals for the early stages of launch. To communicate the QESNAS clinical superiority versus the PPI, drive awareness with physicians and build access for commercial patients. Today I'm proud to share that we're delivering on those goals. Prescribers have quickly recognized the QESNAS differentiated and novel mechanism of action. Our reps are even sharing stories of physicians echoing the Quesna's rapid, potent and durable acid suppression profile. Excitement is translating into demand with thousands of scripts being written since product became available. After over 30 years since the first PPI was approved, there is strong demand for something new. Further, the number of patients who have used the Quesna is growing daily. For me, this is one of the most rewarding elements of our launch. Through our reps, employees, and sometimes even friends and family, I'm hearing stories of long-suffering patients who are experiencing noticeable improvement with the Quesna. We're working hard to ensure as many patients as possible can access the Quesna and share that experience. In fact, with our recent ExpressGrips win, we're well on our way to securing widespread coverage for commercial patients. These early indicators, along with Benoprazan's massive commercial success in Japan, have reinforced my belief in Bequesna's bright future here in the U.S. With an erosive GERD market of approximately 7 million U.S. adults, positive feedback from physicians and patients, and anticipated label expansions, we remain confident in our belief that Bequesna has the potential to reach annual peak revenues of greater than $3 billion. As for our early launch data, I'm happy to report that over 3,800 prescriptions have been filled for the Quesna products. For clarity, this includes scripts captured by Acuvia as well as those that were filled through BlinkRx. We specify filled because we have simultaneously been monitoring an estimate of total demand. which we believe paints a comprehensive picture of the early and growing position interest in writing the Quesna products. We estimate upwards of 14,000 total prescriptions have been written launched to date. We're pleased with this magnitude of total demand and see it as an indicator of what's on the horizon for the Quesna as we continue pursuing broad payer coverage. Last month, the Quesna was added to express scripts, national formularies, for commercial patients. In line with our goal, we secured placement with a single step edit through a generic PPI. As a result, the Quesna bottle's access expanded to an estimated 60 million commercially covered lives. We believe our ability to obtain commercial formulary placement was one of the nation's largest PBMs so quickly after approval indicates that our pricing and access strategy is resonating well with payers. We remain actively engaged with other major PBNs and health plans, and we expect further expansion of commercial coverage throughout 2024. Ultimately, as this coverage comes online, we anticipate the gap between total demand and field scripts will narrow significantly. As we continue to execute on the launch, our R&D team remains focused on advancing pipeline opportunities for Vinoprazen. In December, we announced that the FDA had accepted our non-erosive GERD daily dosing NDA and assigned the PDUFA target action date of July 19, 2024. We are now only four months away from that decision date. Non-erosive GERD represents the largest subcategory of GERD. with an estimated 15 million US adults diagnosed and treated for the disease annually. If approved, this indication will significantly broaden the Quesna's addressable population, and we believe further accelerate uptake. The review of our application is proceeding as expected, and we continue to plan for July launch in this sizeable indication. As for further development, We anticipate initiating a Phase 3 trial for as-needed non-erosive GERD and a Phase 2 trial for eosinophilic esophagitis later this year. We believe Venoprazan's unique MOA bodes well for success in these two trials. If approved, these additional label extensions will further differentiate Venoprazan relative to PPIs and continue to expand the total addressable market for the Quezna products. We're excited about these programs and anticipate sharing more information about our progress in the future. Later in the call, Molly will further detail our fourth quarter and full year 2023 financials, for which we reported revenues of $682,000 and ended the year with $381 million in cash. Overall, we believe our strong balance sheet will enable us to continue delivering on our launch and development strategies. I've previously stressed several foundational dynamics that are necessary for a potential blockbuster drug. These included a significant addressable market, clear unmet need among patients, demonstrated superiority and physician demand. The qualitative feedback from these early months of launch has bolstered our belief that these elements are present in the GERD market. It now comes down to us executing on our strategy and this team is poised to deliver. These are exciting times for FADM as we continue to make progress on both the commercial and development fronts. This year is sure to be filled with new milestones and will set the foundation for the future of the Quesna. Our pursuit of becoming the number one prescribed acid suppressant in the US is off to a strong start and we remain steadfast in delivering on our strategy of driving blockbuster potential through continued market expansion. I will now turn the call over to Martin to dive deeper into our launch progress. Martin.
spk11: Thanks, Terri, and hello, everyone. I'd like to first echo Terri's comments that we're very happy with how the launch of Equestria has started. We're progressing as anticipated and our pre-launch research is being validated by the feedback we're hearing from physicians and patients. During today's call, I'll touch on both quantitative and qualitative elements from our launch. But I know many of you on this call are most keen to hear about our script data, so let's start there. Today we're reporting script data as of February 23rd from both Acuvia and BlinkRx, which represents our latest available information. With the second half of our sales force entering the field in early January, this reflects about seven weeks of our full promotional efforts. This has translated to achieving over 3,800 filled prescriptions, which have reached patients' hands. As our reps continue to promote the positions and garner the backing of strengthened commercial coverage, we expect positive script momentum to continue. Additionally, Our KPIs indicate that over 1,200 unique prescribers have written the Vaquesna script that has ultimately been filled. Among those writers, we are already seeing repeat prescribing, which builds our confidence that physicians recognize Vaquesna's value for patients. We are encouraged by the initial breadth of this prescriber base and anticipate it will grow as we further engage with high-volume targets. Another important metric that Terry mentioned was total demand. We estimate that upwards of 14,000 prescriptions have been written since the start of launch. We believe the significant amount of demand to be indicative of the high level of unmet need in the market. It demonstrates that patients are interested in trying something new and physicians are willing to write for Quesna. As you've heard us say historically, providing access to patients is key to converting demand. As with all new products, negotiating coverage with payers is an essential step in achieving a successful launch and this process often takes time. In anticipation, we established a patient support program through BlinkRx, which has meaningfully expanded patient access, resulting in an increased number of filled scripts. Early data shows the use of BlinkRx growing consistently accompanied by positive feedback. However, there are still physicians sending scripts to their patients' long-established retail pharmacies. Although this has led to a proportion of early sequestered prescriptions not being filled, we believe we are well-positioned to convert more of these scripts over time. In the near term, our sales force continues to emphasize the availability of BlinkRx to positions, as it often represents the best option for getting Voquezna into patients' hands. And ultimately, future contracting with PBMs and health plans will increase payer access and narrow the gap between total demand and filled scripts. In fact, with Voquezna now in formulary at the first of the three major PBMs, We are already making progress on that front. The first major PBM contracting win was with Express Scripts, often referred to as ESI. About three weeks ago, we announced the positioning of Equestria on ESI's national formulary. This was a key accomplishment for Fathom, expanding Equestria's availability to roughly 23 million additional commercial lives. Our team was able to secure non-preferred brand status with a single step edit exactly as intended. The single step is with respect to use of generic PPI prescriptions within the last 130 days. These criteria will be evaluated at the pharmacy counter electronically, avoiding any administrative burden for physician or office staff. Alternatively, if the patient used over-the-counter PPIs instead of prescriptions during that time period, they could also satisfy the single step by means of a prior authorization with attestation by their doctor. This latter avenue for access is a significant development as it means ESI patients could potentially access VEQUESNA as a first-line treatment. As intended, this formulary position provides physicians a straightforward path to accessing VEQUESNA for the broadest patient population. VEQUESNA's total commercial coverage now reflects an estimated 60 million commercial covered lives. Achieving this level of commercial access less than three months into product availability is fantastic, but we know there is still work to be done. We believe our progress so far bodes well for our other ongoing negotiations, where we remain focused on securing Viquezna coverage with similar formulary position. We are confident in our strategy and believe it will continue to yield expanded coverage, resulting in an uptick in filled prescriptions throughout the remainder of 2024. Shifting to our promotional efforts, the sales reps continue to report back that Vaquesna is generating enthusiasm with prescribers. Physicians are articulating patients' unmet need and recognizing Vaquesna's value as a treatment option. The reps are focused on their reach and frequency among our full call panel of approximately 52,000 targets. In parallel, we are working diligently to reach patients suffering from the conditions for which Vaquesna is approved. In these early days, we are happy to see that we appear to be making an impact. To date, we've had over 185,000 visits to our consumer website, and we're hearing from physicians' offices that patients are asking about Boquesna. Patient requests are a key component of our demand strategy, and market research conducted with 200 of our target physicians, almost 80% stated they would grant Boquesna upon request for their erosive GERD patients. With this in mind, we plan to initiate a new branded consumer campaign, which has been met with positive and motivating feedback from test audiences. This campaign speaks directly to erosive GERD patients and their symptoms. Most notably, this will include TV commercials on popular streaming services. So if you suffer from erosive GERD, keep an eye out for Viquezna ads on your devices starting later this month. In closing, I'm extremely happy with the commentary we're hearing from prescribers and how it translates into demand. We are successfully executing our launch strategy. With continued promotion to physicians, a broadened consumer campaign, and expanded commercial coverage, we anticipate significant growth in filled prescriptions over the course of 2024. Our teams are energized and committed to our belief in the blockbuster potential for Viquezna. I'll now pass it off to Molly to walk through our financial results. Molly?
spk04: Thank you, Martin, and hello to everyone on the call. I'm happy to share our fourth quarter and full year 2023 financial results with you today. This is a momentous earnings call for Fathom, as it is the first time we are reporting net revenues for our Requisena products. Although revenues reflect about a month of launch activity, we are pleased with the initial results. I'd like to note two items before going into the numbers. First, during this call, we will not be providing financial guidance regarding projected annual revenues, spend, or earnings as we are still early months of launch. Additionally, I will be commenting on both GAAP and non-GAAP financial measures. Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section and can be found in this morning's press release. Now turning to the numbers. For the fourth quarter, 2023, we reported net revenues of $682,000 driven by the initial stocking of wholesalers in December. This reflects a partial quarter of sales given that Voquezna bottles became commercially available as of November 28th and Voquezna packs as of mid-December. Additionally, we reported gross profit of $515,000 for the fourth quarter, 2023, which equates to a gross margin of approximately 76%. The cost of revenues includes royalties owed to Takeda and excludes certain inventory costs which were expensed prior to receiving FDA approval. Note that the royalties owed as part of our Revenue Interest Financing Agreement are not captured in cost of revenues, but rather in other interest expense. Moving down the P&L to our spend, we reported non-GAAP R&D expenses of $6.1 million for the fourth quarter 2023 compared to $14.3 million for the same period in 2022. As for SG&A, we reported non-GAAP expenses of $39.7 million for the fourth quarter 2023 compared to $25.7 million for the fourth quarter 2022. On a full year basis, we reported non-GAAP R&D expenses of $37.6 million for 2023 compared to $65.9 million for 2022. And for SG&A, our non-GAAP expense was $85.2 million for 2023 compared to $82.4 million for 2022. On a full year and quarterly basis, the decrease in R&D expenses was primarily related to lower clinical trial costs as we concluded our Phase III non-erosive GERD daily dosing trial during 2023. Regarding SG&A, our increase in spend was driven by the build-up of our commercial infrastructure and initiation of marketing activities in support of the commercial launch of WCWSNA. Additionally, the most significant reconciling item between GAAP and non-GAAP OPEX expenses for the period with non-cash stock-based compensation largely associated with the besting of performance shares upon the approval of a growth of GERT. Other non-GAAP reconciling items include non-cash interest on a revenue interest financing liability and non-cash interest expense related to the amortization of debt discount. Turning to EPS, we reported GAAP net loss for the fourth quarter 2023 of $79.6 million or $1.39 loss per share compared to $55 million or $1.33 loss per share for the fourth quarter 2022. Non-GAAP adjusted net loss for the fourth quarter for 2023 was $46 million or $0.80 loss per share compared to $42.2 million or $1.02 loss per share for the same period in 2022. As of December 31, 2023, cash and cash equivalents were $381 million. This includes $175 million received during the fourth quarter of 2023 from our Revenue Interest Financing Agreement upon the approval of Rose of Gurdon. Also during the fourth quarter, we announced the expansion of our existing term loan facility with Hercules Capital. The amendment provides access to more favorable terms and an additional $100 million in non-dilutive capital, subject to achievement of certain revenue milestones. With this amendment, we now have a total of $160 million available via our debt facility. We believe we are in a solid financial position and reaffirm our expectation that we have cash runway through the end of 2026 based on our current operating plan, expected product revenues, and funds available under our term loan. Lastly, as we shared previously, we expect nominal revenues during these first couple quarters of launch while payer coverage is materializing. Additionally, I mentioned our fourth quarter 2023 revenues mostly represented inventory stocking by wholesalers. We expect the sell-through of the stocking to take place during the first quarter of 2024, reinforcing our previous comments regarding nominal revenues during these first couple quarters of launch. With that, I'll now turn the call back over to Terri for closing comments. Terri?
spk03: Thank you, Molly, and thank you again to everyone joining us on today's call. Adam's accomplishments in 2023 were nothing short of amazing, and I'm extremely proud of this team. As we round out Q1 and approach Q2, our primary focus is set on securing formal replacement with payers. We've made great progress on that front so far and anticipate expanded commercial coverage throughout the year. As for the back half of 2024, we believe the planned launch of non-erosive GERD daily dosing in July, pending FDA approval, will serve as another key catalyst for driving adoption. We believe Equinza represents a blockbuster opportunity, and this launch is off to an exciting start. The enthusiasm here at Fathom is tremendous, and there is much to look forward to in 2024. Thank you again for joining us today. We appreciate your continued interest and support. I'll now turn it over to the operator to facilitate a 10-minute question and answer session. Operator.
spk02: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment while we compile our Q&A roster. And our first question comes from the line of Yatin Suniha with Guggenheim. Your line is open. Please go ahead.
spk01: Hey, guys. Thank you for taking my question. A couple for me. Could you just talk about the reason for not filling the script other than the coverage? And how long does it take for blank Rx patients to get the coverage?
spk11: Yeah, so yeah, and this is Martin, and I'll take that question. So in terms of the coverage, I'll just reiterate how happy we are with the Express Scripts win. As we've talked about in the past, our objective was to get one step through a PPI, which opens up the broadest market. And I think the additional thing here that we walked away with is that if a patient has only been on an OTC, the physician can do an attestation and then they should have access to the PESNA. So we anticipate that since it was just announced and just became available, we'll start to see an increase in the number of scripts that are getting through the system. And then we would also envision that given this win, and it seems to fit with our strategy, We're very far along in negotiations with other major payers. So we would start to see that coming on board probably during as we enter into Q2 and then going into the rest of the year. The other thing I'll just say is what we've actually been able to do is in terms of supporting that is with BlinkRX. I think you heard me mention that a couple times. Our goal there was really to make sure that, first of all, customers had a good experience. We wanted to address the lack of coverage early on. We also wanted to make sure that commercial patients on Vaquesna, they got on Vaquesna as a physician intended. And then the other thing that was really important to us was that the program that we set up, that the refills were realized that once a patient converted from patient support over to commercial coverage, that went through normal channels.
spk01: Got it. And then just maybe a follow-up and a really quick one. I understand you are in the early phase of a launch and not providing sort of guidance, but could you just talk about your comfort with the consensus out there, which is around 40, 45 million, And then also, if you can talk about the GTN dynamics, where we are and how do you think it's going to evolve and where do you expect to end up in 2024? Thank you.
spk04: Sure. Hi, Yatin. I'll take that. It's Molly. So overall, as you said, we're not providing specific guidance as it relates to our revenues other than reinforcing our previous commentary that we expect very nominal revenues for the first couple quarters of launch as we're building payer coverage and working through the stocking that we that I alluded to in Q4. As it relates to GTN, we are not commenting necessarily on where we are based upon the discussions we have ongoing with the payers. But what we have said previously and will continue to provide some frame of guidance around is the run rate. And what we've said is that we expect between 50 and 65% on a normalized basis from a steady state. Those are the only pieces that we're providing guidance on at this point as we're so early in the launch.
spk05: Thank you.
spk02: And one moment as we move on to our next question. And our next question is going to come from the line of Joseph Stringer with Needham and Company. Your line is open. Please go ahead.
spk12: Hi. Good morning. Thanks for taking our questions. gave some very helpful info on the contribution to field scripts from BlinkRx since launch. But just curious if you can comment on the relative proportion so that Blink IQVIA split, was it higher or lower in 4Q23 than what it is in the first quarter of this year to date? And maybe as a follow-up to that, can you provide any qualitative guidance on how you see that relative split trending as the launch goes on and, of course, more coverage is secured. Would you expect that to trend down and reach a steady state level at some point?
spk11: Yeah, good morning. Good morning, Joey. So I'll take the first part of your question. I think there were two parts there. Yeah, so what we see is that the utilization of BlinkRx is growing over time, which is exactly what we intended. And, you know, we communicated to you all and are strongly communicating to physicians that it's the best opportunity for ensure patient gets access to Voquesna. So you would assume that since the launch that continues, both in 2023 up until this point, that the utilization of BlinkRx grows. I do just want to clarify though for you an important point in terms of the filled scripts. So as you take a look and you think about the scripts that you're seeing in Acuvia, those were actually filled at retail. Anything else that we're saying above and beyond that was actually part of the bills that took place at BlinkRx. So we would envision to the second part of your question is that split will remain consistent and then we'll start to change and shift more over to retail as we get more wins in.
spk05: Great.
spk12: Thank you so much for the color.
spk02: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
spk13: Great. Thank you, and good morning, everyone. I just wanted to maybe follow up a little bit on the previous question with regard to the pace of conversion between Blink and filled scripts and so forth. I guess as you think about that ratio over the course of the next 12 to 18 months, Do you all expect it to evolve more linearly, or do you sort of see step function changes as coverage is added here, including like when such as the recent Express Scripts ad? And then I had a pipeline question.
spk11: Yeah, so, Paul, I'll take that question again. So I think that you'll see that change over time based upon access. So early on, in the very early weeks of launch, obviously we had no access. So what went into Blink was clearly filled from a patient. They received the prescription and they used our patient support program. Going forward, as we have more access and there's more wins with payers, when those scripts come in, they'll be immediately identified as having commercial coverage and will be filled at retail.
spk13: Okay, got it. And then a pipeline question. The EOE program is really interesting. I noticed in the press release, you know, you guys referenced, you know, PPI as off-label or unapproved treatment. But I'm just curious, you know, how you're thinking about the study population, particularly in the recent light of Budesonide being approved for that population, as well as Dupixent. And so I'm just curious, are you thinking about this study as a treatment-naive population or a post-steroid, post-biologics population as your initial study population and maybe, you know, subsequent studies in other populations down the road. Thank you very much.
spk03: Hey, Paul. Thanks for your question. I'll kick it off and then I'll pass over to Avni. So we're finalizing the protocol for the ismophilic esophagitis phase two. We're really excited about that. And as you know, PPIs are utilized first line but are not approved. And so our positioning in the treatment paradigm would be pre-biologic first line. And so that's what we're pursuing there. And we intend to initiate that phase two by year end. But maybe, Azmi, do you have any other comments?
spk07: Yeah. I mean, we're definitely targeting first line. We're looking at broader population because, remember, this is a phase two. So we need to understand the performance in different population segments. But the intent is to be first line, pre-biologic, as patients will start with a similar treatment that hopefully will be able to show it's effective.
spk05: Thank you. Thank you.
spk02: And one moment as we move on to our next question. And our next question is going to come from the line of Uma Rafat with Evercore. Your line is open. Please go ahead.
spk06: Hi, guys. Thanks for taking my question. I have a couple here, if I may. First, could you remind us, there was some confusion on whether the uptake in IMS, especially what was observed in January, was that a function of IMS just doing a better job capturing blink, or was that completely exclusive? Maybe a different way of answering that is the significant sort of acceleration we saw almost tripling in TRX heading into January, February. Was that also seen in the prescriptions today that you guys saw? And I have a couple of follow-ups.
spk11: Yeah, good morning, Umar. So I think what your question was specifically asking about the Acuvia data and anything uptick or anything else in January, what that is is any script that has gone through a retail channel is being picked up by Acuvia. So that's all scripts realized through normal retail channels.
spk06: But I guess just to clarify, the acceleration seen in prescription pickup, which is over a doubling of TRX, was that something also observed in the prescription fill rate you guys were seeing as well, the overall prescriptions?
spk11: Yeah, we're seeing the same patterns between Blink and anything that's filled by Blink and anything that's filled by Pecuvia. But what you're seeing on a weekly basis through IQVIA are all scripts that are filled through retail means.
spk06: Okay, got it. That's great. Now, the next one is really around some of the stuff, the data points you guys shared. So we know by IQVIA, the total prescriptions reported so far are just under 2,000 or so. You guys implied 3,800 have been filled. So is it reasonable to assume that the IQVIA to Blink ratio is about one-to-one right now? Is that reasonable?
spk11: Yeah, I think it's a pretty good assumption, Noomer.
spk06: Got it. And I guess the last point would be, how do you think about the prescriptions being filled up? Is that because of some payment issue? Because presumably through Blink, people are able to pay $50 or $75 and get it. So why would there be 10,000 or so prescriptions not picked up?
spk11: Yeah, so physicians have obviously, when they're writing a prescription, have the ability to send it anywhere. And that's a really important point that PhilQuest is available at all retail pharmacies. Blink overall is a new service. We are creating change at the same time. What we're seeing is utilization growing at Blink. We're seeing a weekly demand growing at Blink, meaning there's new physicians coming in and there's repeat physicians coming in. So we would expect over time as more physicians start to use Blink, you might see that gap start to narrow. Simultaneously, as we have more wins, the gap is also going to narrow. So there's, you know, we're in early weeks of the launch humor, so there's a lot of variation that we're seeing in the midst of a launch, and then on a very positive side, we'll see more variation in things such as this going forward.
spk06: Okay, excellent. Thank you very much.
spk11: You're welcome.
spk02: Thank you, and one moment as we move on to our next question. And our next question is going to come from the line of Matthew Caulfield with HC Blainwright. Your line is open. Please go ahead.
spk10: Great. Hi. Good morning, guys. And congrats on the launch progress. So based on the current erosive labeling, do you have a sense of whether any non-erosive patients or patients that are possibly unconfirmed, if their disease is erosive or non-erosive, are included in the current script launch numbers, either Equivia or of the BlinkRx numbers?
spk11: Yeah, thanks for the question. You know, right now, well, not even right now, we're not tracking by indication, but I guess what I should make really clear is we're also not promoting for non-erosive. So, at the same time, we're not measuring any non-erosive utilization.
spk10: Okay, that's helpful. And then just one quick follow-up. So, with the range of the 14 case scripts written to date and the 3,800 plus that were filled, Is that spread at least at this stage in line with what you would have expected for this part of launch?
spk11: Yeah, just to clarify, did you say nationwide?
spk00: Yes.
spk11: Yes. Yeah, no, we're seeing uptake similar across the U.S. We're not seeing differences nationwide. by area of the country, regions. And so, you know, we have the representatives are calling on 52,000 physicians, and they're all getting very similar positive feedback receptivity, and we're seeing uptake across all of the different targets that we're calling on. We're really pleased with the demand. I mean, we see 14,000 scripts, as I mentioned earlier, or I should say written, scripts, and as I mentioned earlier, that we only had our full sales force in place only seven weeks ago. It really shows that the unmet need is there. We're hearing feedback from physicians that they're seeing patients already who had worked quickly within hours, healing results that happened in a very short period of time.
spk10: Okay, great. Thank you, and congrats on the progress.
spk02: Thank you, and one moment for our next question. And our next question is going to come from the line of Chase Knickerbocker with Craig Hallam. Your line is open. Please go ahead.
spk08: Good morning, everyone. You know, obviously great to see with the ESI win. I guess, Martin, what's your confidence level, you know, in kind of recreating the structure there, particularly around, you know, how the PA is structured? you know, pretty simple PA process if it's a simple, you know, automated poll, if they were on RX PPIs, you know, in the last six months or so, and then, you know, a simple attestation on the OTC PPIs. Is that something that you think you can recreate kind of broadly in all your contracts?
spk11: Yeah, so the, Chase, I would say that the confidence that Scripps will go through for Express Scripps National Formulary is we're absolutely confident of that. What I'll also say is, and I believe Teri mentioned this in her opening remarks, we've really progressed with the large payers in terms of getting access for Vukosna. And all of those discussions are centered around the same strategy as one step through a PPI. And I think as we've always, you know, spoke about before, is that is the largest segment given that the majority of patients are already on a PPI. And there's a lot of switching from one PPI to another. There's a lot of OTC add-on. So we see that this is, we really were successful in getting the broadest population possible.
spk08: But then particularly around that kind of the PA, the structure of the PA there and how it functions, that's something that you think, you know, you can recreate on the other large formularies? And then also, I just want to dig in a little bit on the characteristics of the early writers so far. They largely GI docs, you know, should we think of them as higher volume. Obviously, it's just a couple, you know, scripts filled per prescriber today. Just some color there would be helpful.
spk11: Yeah, so I'll take the first part of the question in terms of the OTC, you know, the PA associated with that. So listen, this is clearly something that's on the table for discussion. And, you know, our best case was and will always be one step through a PPI. I would take that addition of a PA for an OTC patient is beyond the best case. So I feel really confident about our best case and very hopeful that we can also get that additional PA. In terms of utilization thus far, our sales force has been very focused on calling on the highest volume physicians in the category. And as you can imagine, when you lay all that out, the majority of them who fit in the highest volume are gastroenterologists. So as a result, what we're seeing out of the gate is our largest group of prescribers are GIs. However, I'll say what's really nice in there is they've got a real strong base in those offices of nurse practitioners or physician assistants. We're seeing uptake among them. They're actually often both the first-line prescriber as well as those who are accountable for switches. And then we're just starting to see prescriptions amongst primary care as we start reaching out to that group.
spk08: Got it. That makes sense. And then lastly, just one for Molly. Quite a bit of stock-based comp in the quarter. Is that, you know, kind of one-time new employee sort of stock comp? And then, you know, that's it for me. Thank you.
spk04: Yep. Hi, Chase. Yeah, so that related to the PSUs associated with the approval of erosive GERD. So 19.3 of that was I'd characterize as a one-time event.
spk08: Great. Thanks, Molly.
spk02: Thank you. And one moment for our next question. And our last question is going to come from the line of Yutin Suniha with Guggenheim. Your line is open. Please go ahead.
spk01: Thank you. Just one follow-up, which is around the spend rate, obviously, with DTC campaign. Just curious if you can articulate how should we model the spend in 2024? Thank you.
spk04: Yeah, so we're not providing any additional commentary as it relates to guidance on spend, Jotun, but what we can say with confidence is that the spend that we're anticipating for DTC is well within our guidance for the cash runway, and we feel comfortable that we still have runway through 2026. Very good.
spk01: Thank you.
spk02: Thank you. This does close today's question and answer session. Ladies and gentlemen, this also does conclude today's conference call. Thank you for participating, and you may now disconnect. Everyone have a great day. So, Bye. Thank you. Thank you. Thank you. Hello, and welcome to the Fathom Pharmaceuticals fourth quarter
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